Janssen Vaccines & Prevention, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, is dedicated to bringing meaningful innovation to global health. Our teams focus on the discovery, development, manufacture and marketing of vaccines and antibodies to protect people worldwide from infectious diseases.
In our organization, entrepreneurial people are working in a dynamic culture in which innovation and a 'can do' state of mind are the central points. In order to strengthen our team, we are continuously looking for enthusiastic, talented people who have the ambition to develop themselves and can be of value to Janssen.
The individual supports the Fill/Finish Specialist in all GMP-related activities for the preparation, execution and follow-up actions (when applicable) of aseptic DP manufacturing at external sites. The main responsibility is to maintain the quality level of the FFP group within the DPD department, in compliance with the most recent GMP guidelines and applicable global Janssen procedures and standards. The individual is accountable for the proper and timely documentation of quality records, management of internal documentation system, organization and maintenance of overview of (pre-) clinical DP distribution.
* Ensuring and maintaining a state of inspection readiness of the group, as well as facilitating audits and inspections.
* Key user of the Janssen Quality System (ETS), responsible of creation and on-time closure of change controls, events/deviations and CAPAs.
* Continuous improvement of internal procedures, working closely with interfacing departments
* Keeping track of relevant regulatory guidelines of external manufacturing in general and aseptic drug product manufacturing specifically.
* Defining and monitoring key performance indicators for the group and the CMOs on production planning, deviations, Change Controls, CAPAs, PiP reports, DP storage, DP inventory management
* Organizing and monitoring (pre-)clinical DP distribution, from and to external sites
* Oversight of storage and distribution of (pre-)clinical supplies
* Support in the creation documents in the Janssen Documentation System (DocSpace)
* Maintain the training strategy and program for the whole department, maintain the Training System (ComplianceWire) content
* Requesting POs and being the contact person of the ordering process within the group/department
Key Performance Indicators:
* Departmental Quality System Matrix are within the site acceptance criteria
* Keep FFP procedures up-to-date and effective
QualificationsSpecific professional/technical requirements:
Education: MSc/BSc or equivalent
Languages: English Specific
Knowledge: In-depth knowledge of GMP manufacturing guidelines, preferably of aseptic manufacturing.
Experience: At least 4-6 years of experience in QA and/or aseptic drug product manufacturing. Experience in (bio-) pharma industry is highly desirable.
Other: Collaborative, pro-active, flexible and able to work accurately. A strong quality mindset, as well as excellent organizational and communication skills is key.
What’s in it for you…?
“Caring for the world, one person at a time…”
As an employee we consider you as our most valuable asset.
We take your career seriously.
As part of a global team in an innovative environment your development is key and our day-to-day responsibility.
Through e-university, on the job training, various projects and programs, we ensure your personal growth. Primary Location
Janssen Vaccines & Prevention BV (8852)Job Function